Agilent Technologies M4735A User manual

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User’s Guide
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About This Edition
Edition 1
Printed in the USA
Publication number M4735-91900
The information in this guide applies to
the M4735A Heartstream XL, release
A.00. This information is subject to
change without notice.
Agilent Technologies shall not be liable
for errors contained herein or for inci-
dental or consequential damages in con-
nection with the furnishing,
performance, or use of this material.
Edition History
Edition 1, September, 2000
Copyright
Copyright © 2000
Agilent Technologies, Inc.
3000 Minuteman Road
Andover, MA USA 01810-1099
[phone]
This document may not be photocopied,
reproduced, or translated to another lan-
guage without prior written consent of
Agilent Technologies.
SMART Biphasic is a registered
trademark of Agilent Technologies.
Use of supplies or accessories other
than those recommended by Agilent
Technologies may compromise product
performance.
THIS PRODUCT IS NOT INTENDED
FOR HOME USE.
IN THE U.S., FEDERAL LAW
RESTRICTS THIS DEVICE TO
SALE ON OR BY THE ORDER
OF A PHYSICIAN.
Medical Device Directive
The M4735A Heartstream XL Defibril-
lator/Monitor complies with the
requirements of the Medical Device
Directive 93/42/EEC and carries the
0123 mark accordingly.
Authorized EU-representative:
Agilent Technologies
Deutschland GmbH
Herrenbergerstr.130
D 71034 Boeblingen, Germany
Fax: [phone]
Warning
Radio frequency (RF) interference from
nearby transmitting devices may
degrade the performance of the
M4735A Heartstream XL Defibrillator/
Monitor. Electromagnetic compatibil-
ity with surrounding devices should be
assessed prior to using the defibrillator/
monitor.

v
Index
This guide uses the following conventions:
:$51,1* Warning statements describe conditions or actions that can result
in personal injury or loss of life.
&$87,21 Caution statements describe conditions or actions that can result in
damage to the equipment or loss of data.
127( Notes contain additional information on usage.
7(;7 represents messages that appear on the display
represents softkey labels that appear on the display above or
below the button to which they correspond
6RIWNH\

vi

vii
Contents
Introduction
Overview ............................................................................................................................... 1-2
Intended Use ......................................................................................................................... 1-4
Defibrillation Therapy .......................................................................................................... 1-4
Indications for AED Therapy .........................................................................................1-5
Contraindications for AED Therapy ...............................................................................1-5
Indications for Manual Defibrillation Therapy ............................................................... 1-6
Contraindications for Manual Defibrillation Therapy ....................................................1-6
Precautions for Manual Defibrillation Therapy .............................................................. 1-6
Noninvasive Pacing Therapy (Optional) .............................................................................. 1-7
Indications ....................................................................................................................... 1-7
Contraindications ............................................................................................................ 1-7
SpO2 Monitoring (Optional) ................................................................................................ 1-7
Indications ....................................................................................................................... 1-8
Contraindications ............................................................................................................ 1-8
Safety Considerations ........................................................................................................... 1-8
Documentation and Training ................................................................................................ 1-9

viii
Contents
Getting Started
Getting Acquainted ............................................................................................................... 2-2
Basic Orientation ............................................................................................................ 2-2
Manual Mode Controls ..................................................................................................2-5
Display Buttons ............................................................................................................... 2-6
Display Layout ................................................................................................................ 2-7
Connecting to Power ............................................................................................................. 2-9
Inserting the Battery ...................................................................................................... 2-10
Removing the Battery ................................................................................................... 2-11
Low Battery Warning ...................................................................................................2-12
Using a Data Card (Optional) ............................................................................................. 2-13
Inserting a Data Card .................................................................................................... 2-14
Removing a Data Card ..................................................................................................2-15
Defibrillating in AED Mode
Overview ............................................................................................................................... 3-3
Defibrillation (using the default configuration) .............................................................. 3-4
Defibrillation (with a modified configuration) ...............................................................3-5
Preparation ............................................................................................................................ 3-6
Defibrillating ......................................................................................................................... 3-7
Automatic Re-analysis On ...................................................................................... 3-13
Automatic Re-analysis Off ..................................................................................... 3-13
Pausing for CPR .................................................................................................................. 3-14
Monitoring Rhythm ............................................................................................................ 3-16
ERC Protocol ...................................................................................................................... 3-18
Troubleshooting .................................................................................................................. 3-20

ix
Contents
Monitoring the ECG
Overview ............................................................................................................................... 4-2
Connecting the ECG Patient Cable ....................................................................................... 4-3
Applying Monitoring Electrodes .......................................................................................... 4-4
Electrode Placement ....................................................................................................... 4-5
Selecting the Lead .................................................................................................................4-7
Setting the Heart Rate Alarm ................................................................................................4-9
Disabling the HR Alarm ..................................................................................................... 4-10
Adjusting the ECG Size ...................................................................................................... 4-10
Adjusting the ECG Volume ................................................................................................ 4-10
Troubleshooting .................................................................................................................. 4-11
Monitoring SpO2
Introduction ........................................................................................................................... 5-2
Understanding Pulse Oximetry ............................................................................................. 5-3
Selecting a Sensor ................................................................................................................. 5-4
Reusable Sensors ............................................................................................................ 5-5
Disposable Sensors ......................................................................................................... 5-5
Applying the Sensor .............................................................................................................. 5-6
Connecting the Sensor Cable ................................................................................................ 5-7
Monitoring ............................................................................................................................ 5-8
Setting Alarms ...................................................................................................................... 5-9
Responding to an Alarm ....................................................................................................... 5-9
Discontinuing SpO2 Monitoring ........................................................................................ 5-10
Caring for Sensors .............................................................................................................. 5-10
Troubleshooting .................................................................................................................. 5-11

x
Contents
Defibrillating in Manual Mode
Manual Mode Display .......................................................................................................... 6-2
Enabling Manual Mode ........................................................................................................ 6-2
Defibrillating in Manual Mode ............................................................................................. 6-3
Using External Paddles ...................................................................................................6-3
Using Multifunction Defib Electrode Pads .....................................................................6-5
Defibrillation Procedure ................................................................................................. 6-6
1. Select Energy ........................................................................................................6-6
2. Charge ................................................................................................................... 6-7
3. Shock .................................................................................................................... 6-8
Entering AED Mode ............................................................................................................ 6-9
Performing Synchronized Cardioversion
Using Multifunction Defib Electrode Pads ...........................................................................7-2
Using 3 or 5-wire ECG Leads ............................................................................................... 7-3
Using External Paddles .........................................................................................................7-4
Delivering a Synchronized Shock ......................................................................................... 7-5
Using External ECG Monitors ..............................................................................................7-7
Delivering Additional Synchronized Shocks ........................................................................ 7-7
Disabling Sync Mode ............................................................................................................7-7

xi
Contents
Pacing (Optional)
Pacing Operational Controls .................................................................................................8-2
Demand Mode Versus Fixed Mode ...................................................................................... 8-2
Monitoring During Pacing .................................................................................................... 8-3
Preparing for Pacing ............................................................................................................. 8-3
Performing Pacing ................................................................................................................ 8-5
Changing Pacing Modes ....................................................................................................... 8-8
Defibrillating During Pacing ................................................................................................ 8-8
Troubleshooting .................................................................................................................... 8-9
Storing, Retrieving & Printing
Overview ............................................................................................................................... 9-2
Marking Events ..................................................................................................................... 9-3
Events Recorded ................................................................................................................... 9-4
Creating a Patient Record .....................................................................................................9-6
Printing the Internal Event Summary ...................................................................................9-7
Printing Events ...................................................................................................................... 9-9

xii
Contents
Setting Up and Configuring the Heartstream XL
Connecting/Disconnecting Patient Cables .......................................................................... 10-2
Pads/Paddles Patient Cable ........................................................................................... 10-3
SpO2 Patient Cable ....................................................................................................... 10-5
ECG Patient Cable ........................................................................................................ 10-6
Configuring the Heartstream XL ........................................................................................10-7
Accessing the Configuration Menu .............................................................................. 10-7
Configurable Parameters ............................................................................................... 10-8
Modifying the Configuration ...................................................................................... 10-13
Returning to the Default Configuration ...................................................................... 10-13
Saving Settings to a Data Card ................................................................................... 10-14
Loading Settings from a Data Card ............................................................................10-14
Printing Settings .......................................................................................................... 10-14

xiii
Contents
Maintaining the Heartstream XL
Operational Checks ............................................................................................................. 11-2
Every Shift .................................................................................................................... 11-2
Every Month ................................................................................................................. 11-2
Every Three Months ..................................................................................................... 11-2
Using External Paddles .................................................................................................11-3
Using Pads .................................................................................................................... 11-4
Battery Capacity Test .................................................................................................... 11-6
Battery Maintenance ........................................................................................................... 11-7
Recharging Batteries ..................................................................................................... 11-8
Battery Capacity ........................................................................................................... 11-9
Battery Life Expectancy ............................................................................................... 11-9
Storing Batteries ........................................................................................................... 11-9
Discarding Batteries ...................................................................................................... 11-9
Loading Printer Paper .......................................................................................................11-10
Cleaning Instructions ........................................................................................................ 11-12
Cleaning the Heartstream XL ..................................................................................... 11-12
Cleaning the Printer Printhead .................................................................................... 11-12
Cleaning Paddles, Pads, Electrodes & Cables ............................................................ 11-13
Supplies & Accessories .................................................................................................... 11-14
Disposing of the Heartstream XL .....................................................................................11-17

xiv
Contents
Troubleshooting
System Messages ................................................................................................................ 12-2
Momentary Messages ................................................................................................... 12-5
Troubleshooting Tips .......................................................................................................... 12-7
Calling for Service .............................................................................................................. 12-8
United States of America ..............................................................................................12-8
Canada .......................................................................................................................... 12-8
Other International Areas .............................................................................................. 12-8
Specifications & Safety
Specifications ...................................................................................................................... 13-2
Defibrillator .................................................................................................................. 13-2
ECG Monitoring ........................................................................................................... 13-5
...................................................................................................................................... 13-7
Display .......................................................................................................................... 13-8
Battery ........................................................................................................................... 13-8
Thermal Array Printer ................................................................................................... 13-9
Noninvasive Pacing .................................................................................................... 13-10
SpO2 Pulse Oximetry ................................................................................................. 13-11
Event Storage .............................................................................................................. 13-11
Environmental ............................................................................................................. 13-12
Symbol Definitions ........................................................................................................... 13-14
Clinical Performance Summary ........................................................................................ 13-19
Methods ...................................................................................................................... 13-19
Results ......................................................................................................................... 13-19
Conclusion .................................................................................................................. 13-20
Safety Considerations ....................................................................................................... 13-21
Electromagnetic Compatibility ......................................................................................... 13-25
Reducing Electromagnetic Interference ......................................................................13-26
Restrictions for Use .................................................................................................... 13-27
Immunity Level ........................................................................................................... 13-27

M4735A Heartstream XL Defibrillator/Monitor 1-1
1
1Introduction
The M4735A Heartstream XL Defibrillator/Monitor is designed to meet your
resuscitation and monitoring needs. This guide provides instructions for safe
and proper operation, set-up, configuration, and care of your
M4735A Heartstream XL Defibrillator/Monitor.
In this chapter, you’ll find general information that you should become famil-
iar with before using the defibrillator/monitor.

Overview
1-2 Introduction
Overview
The M4735A Heartstream XL Defibrillator/Monitor is a lightweight, porta-
ble, semi-automatic external defibrillator. It offers two modes of operation for
defibrillation:
l Automated External Defibrillation (AED) Mode
l Manual Mode
Both modes incorporate a low energy SMART Biphasic waveform for
defibrillation.
In AED Mode, the M4735A Heartstream XL Defibrillator/Monitor analyzes
the patient’s ECG and advises you whether or not to deliver a shock. Voice
prompts guide you through the defibrillation process by providing instruc-
tions and patient information. Voice prompts are reinforced by messages that
appear on the display.
In Manual Mode, the M4735A Heartstream XL Defibrillator/Monitor turns
control of the defibrillation process over to you. You analyze the patient’s
ECG, and select the energy setting for defibrillation if necessary. Manual
Mode also allows you to perform synchronized cardioversion and offers
noninvasive pacing (optional).
Defibrillation is performed through attached paddles or multifunction defib
electrode pads. Monitoring is available in AED and Manual Mode through
pads, 3-lead ECG monitoring electrodes, or optional 5-lead ECG monitoring
electrodes. Optional pulse oximetry (SpO2) monitoring is also available in
AED and Manual Modes. While monitoring ECG or SpO2, you may set heart
rate and/or SpO2 alarms to alert you when these parameters are outside the
defined limits.

Overview
M4735A Heartstream XL Defibrillator/Monitor 1-3
1
The M4735A Heartstream XL Defibrillator/Monitor automatically stores crit-
ical events in its internal memory, such as shocks and alarm violations. Addi-
tional events of interest may also be marked for storage. These events can be
printed as they occur or as part of an Event Summary. The M4735A Heart-
stream XL Defibrillator/Monitor also enables you to store data and events on
an optional Data Card for downloading to CodeRunner Web Data Manage-
ment Systems.
The versatile M4735A Heartstream XL Defibrillator/Monitor is highly con-
figurable to better meet the needs of diverse users. The messages and softkeys
vary, depending on how the M4735A Heartstream XL Defibrillator/Monitor
is configured. Be sure to familiarize yourself with your configuration before
using the M4735A Heartstream XL Defibrillator/Monitor (see “Configuring
the Heartstream XL” on page 10-7).
The M4735A Heartstream XL Defibrillator/Monitor is powered by AC power
and a rechargable sealed lead acid (SLA) battery which allows the defibrilla-
tor to charge to 200 joules in less than three seconds. Proper care of your bat-
teries will ensure that they have the energy required to operate the M4735A
Heartstream XL Defibrillator/Monitor and to deliver the appropriate therapy.
(See “Battery Maintenance” on page 11-7.) Similarly, performing the speci-
fied operational checks will ensure that the M4735A Heartstream XL
Defibrillator/Monitor is functioning properly and ready for use. (See “Opera-
tional Checks” on page 11-2.)

Intended Use
1-4 Introduction
Intended Use
The M4735A Heartstream XL Defibrillator/Monitor is for use in the hospital
by qualified medical personnel trained in the operation of the device and qual-
ified by training in basic life support, advanced cardiac life support, or
defibrillation. It must be used by or on the order of a physician.
When operating as a semi-automatic external defibrillator in AED Mode, the
M4735A Heartstream XL Defibrillator/Monitor is suitable for use by medical
personnel trained in basic life support that includes the use of an AED.
When operating as a defibrillator/monitor in Manual Mode, the M4735A
Heartstream XL Defibrillator/Monitor is suitable for use by emergency medi-
cal personnel trained in advanced cardiac life support.
Defibrillation Therapy
Defibrillation therapy is the definitive method for termination of a variety of
potentially fatal arrhythmias. The M4735A Heartstream XL Defibrillator/
Monitor provides this therapy through the application of a brief biphasic pulse
of electricity to the cardiac muscle. This electrical energy is transferred
through attached paddles or disposable multifunction defib electrode pads
applied to the patient’s bare chest.
NOTE Successful resuscitation is dependent on many variables specific to the
patient’s physiological state and the circumstances surrounding the patient
event. Failure to have a successful patient outcome is not a reliable indicator
of defibrillator/monitor performance. The presence or absence of a muscular
response to the transfer of energy during electrical therapy is not a reliable
indicator of energy delivery or device performance.

Defibrillation Therapy
M4735A Heartstream XL Defibrillator/Monitor 1-5
1
Indications for AED Therapy
An AED is to be used in the presence of a suspected cardiac arrest on patients
of at least 8 years of age that are:
l Unresponsive
l Not breathing
l Pulseless
Contraindications for AED Therapy
An AED is not to be used on patients that exhibit one or any combination of
the following:
l Responsiveness
l Spontaneous breathing
l Palpable pulse
Precautions for AED Therapy
The AED algorithm is not designed to handle erratic spiking problems caused
by a properly or improperly functioning pacemaker. In patients with cardiac
pacemakers, the M4735A Heartstream XL Defibrillator/Monitor may have
reduced sensitivity and not detect all shockable rhythms.
NOTE The AED algorithm is not intended for children under 8 years of age. For chil-
dren older than 8 years, the American Heart Association recommends that
standard operating procedures for AEDs be followed. American Heart Asso-
ciation Textbook of Advanced Cardiac Life Support. Dallas, Texas.:
AHA; 1997.

Defibrillation Therapy
1-6 Introduction
Indications for Manual Defibrillation Therapy
Asynchronous defibrillation is the initial treatment for ventricular fibrillation
and ventricular tachycardia, in patients who are pulseless and unresponsive.
The SMART Biphasic waveform utilized in the M4735A Heartstream XL
Defibrillator/Monitor has undergone clinical testing in adults. These trials
support the waveform’s effectiveness for defibrillation of ventricular
tachyarrhythmias at the 150J setting.
In manual mode operation, the M4735A Heartstream XL Defibrillator/Moni-
tor incorporates some user selectable lower energylevels that were not used in
the clinical trials.
There are currently no clinical studies related to the use of the SMART
Biphasic waveform in pediatric applications or in direct defibrillation of the
heart during open chest surgery.
Contraindications for Manual Defibrillation Therapy
Asynchronous defibrillation therapy is contraindicated in patients that exhibit
one or any combination of the following:
l Responsiveness
l Spontaneous breathing
l Palpable pulse
Precautions for Manual Defibrillation Therapy
Defibrillating asystole can inhibit the recovery of natural pacemakers in the
heart and completely eliminate any chance of recovery. Asystole should not
be routinely shocked.